A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)

NCT ID: NCT05376176

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-19

Study Completion Date

2025-05-26

Brief Summary

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This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.

Detailed Description

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Conditions

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Fuchs Endothelial Corneal Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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STN1010904 ophthalmic suspension 0.03% BID

Group Type EXPERIMENTAL

STN1010904 ophthalmic suspension 0.03% BID

Intervention Type DRUG

0.03% STN1010904 ophthalmic suspension BID

STN1010904 ophthalmic suspension 0.1% BID

Group Type EXPERIMENTAL

STN1010904 ophthalmic suspension 0.1% BID

Intervention Type DRUG

0.1% STN1010904 ophthalmic suspension BID

Placebo Vehicle BID

Group Type PLACEBO_COMPARATOR

Placebo (Vehicle) BID

Intervention Type DRUG

Placebo (vehicle) BID

Interventions

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STN1010904 ophthalmic suspension 0.03% BID

0.03% STN1010904 ophthalmic suspension BID

Intervention Type DRUG

STN1010904 ophthalmic suspension 0.1% BID

0.1% STN1010904 ophthalmic suspension BID

Intervention Type DRUG

Placebo (Vehicle) BID

Placebo (vehicle) BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female diagnosed with FECD.

Exclusion Criteria

* Females who are pregnant or lactating.
* Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO) in the study eye.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ActualEyes Inc.

UNKNOWN

Sponsor Role collaborator

Santen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stein Eye Institution UCLA

Los Angeles, California, United States

Site Status

Price Vision Group

Indianapolis, Indiana, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Tauber Eye Center

Kansas City, Missouri, United States

Site Status

Comprehensive Eye Care, Ltd

Washington, Missouri, United States

Site Status

Metropolitan Eye Research and Surgery Center

Palisades Park, New Jersey, United States

Site Status

Devers Eye Institute

Portland, Oregon, United States

Site Status

Scott Christie and Associates

Cranberry Township, Pennsylvania, United States

Site Status

UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Houston Eye Associates

Houston, Texas, United States

Site Status

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

University Hospital of Saint-Etienne

Saint-Etienne, , France

Site Status

Medical Research Foundation

Chennai, Tamil Nadu, India

Site Status

Suven Clinical Research CenterL V Prasad Eye Institute

Banjara Hills, Telangana, India

Site Status

Countries

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United States France India

Other Identifiers

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101090401IN

Identifier Type: -

Identifier Source: org_study_id

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